Lifestyle intervention: Lifestyle intervention in the form of individualised dietitian consultation with the overall goal of weight loss.
Intervention includes one initial consultation with a dietician of 1 hour and 15 minutes where participants receive a personalised diet-plan customised to the participants everyday life. After the initial consultation, the participants attend 10 "follow-ups" of about 25 minutes that are spread out over 4-5 months.
Study summary
This study will investigate potential correlations and relationships between obesity and organ-specific complications, including non-alcoholic fatty liver disease (NAFLD), non-alcoholic fatty pancreas disease (NAFPD) and fatty kidney. Furthermore, it will investigate how and if a lifestyle-induced weight-loss intervention decreases liver fat and improve NAFLD.
Furthermore, the study will investigate if extracellular vesicles (EVs) can be used as a biomarker for early detection of any of the above-mentioned by comparing obese individuals with NAFLD and metabolic syndrome with both normal weight controls and obese individuals without NAFLD and metabolic syndrome. Lastly, it will investigate if weight changes and the resulting improvement of NAFLD are accompanied by changes in liver-specific extracellular vesicle (EV) phenotypes.
Eligibility
Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Age 30-60
* BMI between 30,0 - 39,9 kg/m2.
* Signed informed consent.
* Metabolic syndrome
* NAFLD
* Wishes to participate in a weight reduction program.
Exclusion Criteria:
* Diabetes or any significant endocrine, heart, kidney, liver, or malignant disease.
* Pregnancy, planned pregnancy, or breast-feeding during the trial.
* Alcohol abuse or abuse of recreational drugs
* Medical treatment (systemic glucocorticoids, steatosis-inducing drugs, antibiotics up to two months prior to inclusion, or chemotherapy) or participation in clinical trials other than this.
* Excessive weight loss within the last three months (defined as more than 10 kilograms).
* Contraindications for MRI and dual energy x-ray absorptiometry (DEXA)scanning.
* Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the trial procedures.
Primary outcome measure(s)
Effect of weight loss on organ steatosis — 36 months Changes in steatosis of the liver, pancreas and kidneys assessed by magnetic resonance imaging (proton density fat fraction) between baseline, during weight loss, and after weight loss.
Effect of weight loss on plasma alanine transaminase — 36 months Changes in plasma alanine transaminase (IU/L) between baseline, during weight loss, and after weight loss.
Effect of weight loss on BMI — 36 months Changes in BMI between baseline, during weight loss, and after weight loss.
Weight and height will be combined to report BMI in kg/m\^2.
Effect of weight loss on total body fat — 36 months Changes in total body fat (%) as assessed by dual dual energy x-ray absorptiometry between baseline, during weight loss, and after weight loss.
Effect of weight loss on the homeostasis model assessment for insulin resistance — 36 months Changes in Homeostasis model assessment for insulin resistance (HOMA) between baseline, during weight loss, and after weight loss.
Insulin (pmol/L) and plasma glucose (mmol/L) will be combined to calculate HOMA using the iterative structural model.
Effect of weight loss on plasma aspartate transaminase — 36 months Changes in plasma aspartate transaminase (IU/L) between baseline, during weight loss, and after weight loss.
Trial sites (1)
Facility
City
Region
Status
Aalborg University Hospital
Aalborg
North Jutland
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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